MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER; CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number	H21911
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While positioning the catheters and collecting geometry with the mapping system, the touch screen computer shut down and emitted a burning smell and smoke.The procedure was completed without the touch screen computer and there were no patient consequences.
Additional Manufacturer Narrative
One ep-workmate¿ and workmate¿ claris¿ ep-4¿ touchscreen computer was received into the lab for analysis.Visual inspection of the returned device indicated all input and output connectors and labels are free of physical damage.It was also verified all external hardware is secured and no physical damage was observed on the display panel or the exterior casing.Inspection of the internal components revealed a melted power cable connector at the hard disk drive.No additional functional testing was performed as the returned device was received in a condition that does not permit a complete evaluation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER
• Common Device Name: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 7737941
• Report Number: 2184149-2018-00117
• Device Sequence Number: 1050341
• Product Code: DQK
• UDI-Device Identifier: 05414734219112
• UDI-Public: 05414734219112
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H21911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1